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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K972552
Device Name AUDIFON H20 PC/AUDIFON H32 PP
Applicant
Trutone
3113 S. 115th E. Ave.
Tulsa,  OK  74146
Applicant Contact ZIAD SHWIYAT
Correspondent
Trutone
3113 S. 115th E. Ave.
Tulsa,  OK  74146
Correspondent Contact ZIAD SHWIYAT
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/30/1997
Decision Date 07/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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